Recall Z-1596-2015— Arc Medical Inc

Name: FDA recall Z-1596-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-19

Class III · Terminated

Class III FDA medical device recall by Arc Medical Inc, initiated 2015-02-19, terminated 2017-08-29. It names one FDA 510(k) clearance: K903054. Product: ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.. Reason: Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly..

Recalling firm: Arc Medical Inc
Classification: Class III
Status: Terminated
Initiated: 2015-02-19
Terminated: 2017-08-29
Firm location: Tucker, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K903054 — HME-10 (TM)Pharma Systems, Inc.·cleared 1990-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.

Reason for recall

Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

Data sourced from openFDA. This site is unofficial and independent of the FDA.